Colloid or crystalloid for goal directed fluid therapy in patients undergoing elective colorectal surgery
| ISRCTN | ISRCTN41882213 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41882213 |
| Secondary identifying numbers | YOR-A01243 |
- Submission date
- 17/09/2009
- Registration date
- 15/12/2009
- Last edited
- 17/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jonathan Wilson
Scientific
Scientific
Department of Anaesthesia
York District Hospital
Wiggington Road
York
YO31 8HE
United Kingdom
| David.Yates@York.NHS.UK |
Study information
| Study design | Single-centre randomised controlled double-blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Colloid or crystalloid for goal directed fluid therapy in patients undergoing elective colorectal surgery: a randomised, double-blind controlled trial |
| Study objectives | Major surgery generates a strong systemic inflammatory response that in turn leads to an increase in oxygen demand in the peri-operative period. This substantial increase in oxygen demand is normally met by increases in the volume of blood that the heart pumps out each minute (cardiac output) and by increasing the amount of oxygen that the tissues extract from the blood. Most patients can meet this increased oxygen demand by increasing cardiac output and will usually do well after surgery. To increase cardiac output in an efficient way, i.e. by making the heart beat more powerfully rather than just faster, the patient needs to have an optimum amount of blood in their circulatory system. Recent studies have demonstrated that morbidity rates and length of stays in hospital can be improved by giving each individual patient just the right amount of intravenous fluid during their operation. To date, no-one has proven in a randomised trial which type of intravenous fluid anaesthetists should be using to do this. Therefore we propose to carry out a randomised, blinded study looking into the differences between using crystalloid or colloid for perioperative haemodynamic optimisation in a population of medium to high risk patients having colorectal surgery. |
| Ethics approval(s) | Leeds (West) Research Ethics Committee approved on the 8th September 2009 (ref: 09/H1307/77) |
| Health condition(s) or problem(s) studied | Elective surgical resection of the colon |
| Intervention | Patients will receive either Volulyte™, a colloid in balanced salt solution or Hartmann's Solution for intra-operative haemodynamic optimisation guided by stroke volume variation. This will be given blinded as 250 ml boluses. Intervention will take place during the operation only. Follow up will be for 15 days or until hospital discharge. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Volulyte™, Hartmann's Solution |
| Primary outcome measure | Incidence of gastrointestinal morbidity on day 5 following surgery. |
| Secondary outcome measures | 1. Incidence of post operative complications during hospital stay 2. Morbidity at 1, 3, 5, 8, 10 days measured by Postoperative Morbidity Survey 3. Length of stay in hospital after surgery 4. Recovery parameters (time to eating, drinking, and mobilising after surgery) 5. Peri-operative haemodynamic variables (central venous pressure [CVP], heart rate, blood pressure, oxygen delivery, stroke volume variation) 6. Cost effectiveness of the intervention 7. Measurement of inflammatory markers 8. Use of additional inotropic support 9. Use of "rescue colloid" boluses |
| Overall study start date | 01/10/2009 |
| Completion date | 01/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 202 |
| Key inclusion criteria | Patients (both males and females) over 55 years of age undergoing elective colorectal surgery, who after routine cardiopulmonar exercise testing (CPET) at the Pre-assessment Clinic, have been found to have an oxygen uptake at anaerobic threshold (AT) less than or equal to 14.0 ml/kg/min as measured by the V-slope method. |
| Key exclusion criteria | 1. Patients less than 55 years of age 2. Patients having emergency procedures 3. Those who are American Society of Anaesthesiologists (ASA) classification grade 5 4. Patients who refuse or are unable to give informed consent 5. Renal failure with oliguria or anuria not related to hypovolaemia 6. Patients receiving dialysis treatment 7. Intracranial bleeding 8. Known hypersensitivity to hydroxyethyl starches or gelatins 9. Patients with sodium overload 10. Patients who have had inadequate time (less than 24 hours) to consider the Patient Information Leaflet 11. Patients with hypertrophic obstructive cardiomyopathy (HOCM), aortic stenosis, phaeochromocytoma, a low platelet count, or have used a monoamine oxidase inhibitor within the last 14 days |
| Date of first enrolment | 01/10/2009 |
| Date of final enrolment | 01/10/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Anaesthesia
York
YO31 8HE
United Kingdom
YO31 8HE
United Kingdom
Sponsor information
York Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Wiggington Road
York
YO31 8HE
England
United Kingdom
| Website | http://www.yorkhospitals.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/027e4g787 |
Funders
Funder type
Industry
Fresenius Kabi (Germany) - Unrestricted research grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2014 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
